METTLER ELECTRONICS CORP.

Address:1333 SOUTH CLAUDINA ST.,ANAHEIM,CA,92805,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ELECTRODE, CUTANEOUS (GXY) (4) Stimulator, muscle, powered (IPF) (3) Transducer, ultrasonic, diagnostic (ITX) (3) STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF (GZJ) (2)

Premarket Exempt

Clear

Sys*Stim 206 - 00816864020005 Catalog Number : ME 206

Device Description : Powered muscle stimulator, one channel neuromuscular stimulator

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

EZ Trode, 2" round - 00816864020012 Catalog Number : 2221

Device Description : 2" diameter round electrodes with lead wires, 4 electrodes/pkg.

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Sonigel Ultrasound Gel Couplants - 00816864020029 Catalog Number : 1844

Device Description : Sonigel (8.5 oz.tube)

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

EZ Trode, 2.75" round - 00816864020036 Catalog Number : 2222

Device Description : 2.75" diameter round electrodes with lead wires, 4 electrodes/pkg.

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Sonigel Ultrasound Gel Couplants - 00816864020043 Catalog Number : 1851

Device Description : Sonigel (250ml bottle)

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

EZ Trode, 2" square - 00816864020050 Catalog Number : 2224

Device Description : 2" square electrodes with lead wires, 4 electrodes/pkg.

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Sonigel Ultrasound Gel Couplants - 00816864020067 Catalog Number : 1852

Device Description : Sonigel 1852 (1 x 5 liters)

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

EZ Trode, 2" x 5" rectangular - 00816864020074 Catalog Number : 2223

Device Description : 2" x 5" rectangular electrodes with lead wires, 2 electrodes/pkg.

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Sys*Stim 208, one channel - 00816864020098 Catalog Number : ME 208

Device Description : Powered muscle stimulator, one channel

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GZJ, IPF

Prescription Use : Yes

Device Count : 1

Sys*Stim 208A, two channel - 00816864020104 Catalog Number : ME 208A

Device Description : Powered muscle stimulator, two channel

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GZJ, IPF

Prescription Use : Yes

Device Count : 1

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